NCT04156698

Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

A Phase II, Single-center, Open-label, Single-arm Study of Induction Chemotherapy Combined With Immunotherapy for Locally Advanced Hypopharyngeal Carcinoma

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 51 (estimated)
• Sponsor: Eye & ENT Hospital of Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a single-center, multidisciplinary, open-label, single-arm prospective clinical study.

Detailed description

In this study, 51 patients with hypohparyngeal carcinoma will be enrolled, These patients who have locally advanced-stage disease, including TNM stage cT3-4aN0-2M0 (AJCC 7th) and require a total laryngectomy as an initial therapy. Patients who achieved a CR or PR at the primary site after three cycles of TPF-regimen chemotherapy combined with immuotherapy will be referred for definitive RT and immuotherapy, while patients who received an evaluation of PD or SD at the primary site were referred for surgery followed by adjuvant RT/CRT.

Conditions

• Hypopharyngeal Carcinoma
• Immunotherapy
• Chemotherapy

Interventions

Type	Name	Description
DRUG	Docetaxel	Docetaxel is a chemotherapy drug.
DRUG	Cisplatin	Cisplatin is a chemotherapy drug.
DRUG	Capecitabine	Capecitabine is a chemotherapy drug.
DRUG	Camrelizumab	Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.

Timeline

• Start date: 2020-05-21
• Primary completion: 2023-04-16
• Completion: 2026-01-16
• First posted: 2019-11-07
• Last updated: 2023-08-09

Locations

1 site across 1 country: China